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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pediatric hemodialysis system
Definition For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.
Product CodeQIR
Regulation Number 876.5861
Device Class 2


Premarket Reviews
ManufacturerDecision
BELLCO SRL (NOW PART OF MEDTRONIC, INC)
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 2 2
2023 7 7
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 6 6
Smoking 5 5
Protective Measures Problem 5 5
Device Sensing Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Product Quality Problem 2 2
Leak/Splash 2 2
Loss of Power 1 1
Fluid/Blood Leak 1 1
Coagulation in Device or Device Ingredient 1 1
Pumping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 7 7
Hemorrhage/Bleeding 4 4
Ischemia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Anemia 1 1

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